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OpenTrials
Completed

NCT Number: NCT02406430

Prognostic Factors in Epiretinal Membrane Surgery

Retrospective interventional case series study reporting preoperative clinical and anatomical factors associated with visual recovery 1 year after combined cataract and idiopathic epiretinal membrane surgery. Age, duration of symptoms, and preoperative best corrected visual acuity appeared to be reliable prognostic factors. Combining these factors with analysis of the photoreceptors' inner and outer segments junction in spectral-domain optical coherence tomography provides a predictive score to estimate individual chances of good visual recovery

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • symptomatic idiopathic epiretinal membrane operated on between April 2009 and September 2012 at the university hospital of Dijon, France.
  • All patients signed informed consent for the surgical procedure.

Exclusion criteria

  • Patients were excluded if they presented any cause of secondary epiretinal membrane (including diabetic retinopathy, vein occlusion, ocular inflammation, retinal detachment, or previously vitrectomized eye), high myopia (axial length ≥ 26 mm or spherical equivalent ≥ 6 diopters), severe media opacities with weak SD-OCT signal strengths, or any macular or optic nerve disease. Patients with a follow-up of less than 12 months were excluded and only one eye was included in those with bilateral epiretinal membranes.

Treatment and study plan

a combined cataract and ERM surgery

Procedure

All patients underwent a combined cataract and ERM surgery owing to visual impairment or disabling metamorphopsia. A complete ophthalmological examination was performed before and at 1,6, and 12 months after the surgery, including best corrected visual acuity with Snellen charts converted into the logarithm of the minimum angle of resolution, slit-lamp biomicroscopy, indirect fundus, and macular optical coherence tomography

Primary outcomes

  1. Best corrected visual acuity

    Time frame: 1 year after the surgery

    Best corrected visual acuity 1 year after the surgery, and preoperative factors associated with this visual outcome (age, duration of symptoms, initial best corrected visual acuity, and optical coherence tomography findings)

Secondary outcomes

  1. To set up a predictive score for a >= 20/20 best corrected visual acuity

    Time frame: 1 year after the surgery

    To set up a predictive score for a >= 20/20 best corrected visual acuity, 1year after a combined cataract and epiretinal membrane surgery

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

Preoperative Prognostic Factors and Predictive Score in Patients Operated on for Combined Cataract and Idiopathic Epiretinal Membrane.

Important dates

Study start
2009
Primary completion
2013
First posted
Apr 2, 2015
Registry last updated
Apr 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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